Randomized Feasibility Study Comparing the Clinical Utility of the Stereotaxis Navigant™ Computed Tomography Angiography Importation and Co- Registration Feature, the NaviView™ Assisted Navigation Feature, and Standard Angiography
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Stereotaxis
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- The primary endpoint is to compare and evaluate the total contrast use between Groups A, B and C .
研究概览
简要总结
The Stereotaxis Niobe® II Magnetic Navigation System (MNS) is designed to direct and digitally control catheter and guidewire based therapeutic and diagnostic devices along complex trajectories within the heart and coronary vasculature.
Navigation using vectors acquired from the CT Co-registration feature of Navigant™ provides clinical benefits for percutaneous coronary intervention (PCI) by decreasing the amount of contrast used during complex PCI procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be between 18-80 years of age
- •Willing and able to provide prior written informed consent
- •Patients present with a single bifurcated lesion or single non-CTO complex lesion requiring PCI.
- •Able to be safely exposed to magnetic fields, such as magnetic resonance imaging (MRI)
- •CT angiography performed prior to cardiac catheterization (must be performed >48 hours prior to procedure to limit peri-procedural contrast use, but <12 months prior to the procedure)
排除标准
- •Patients with a creatinine greater than 2.0 mg/dL
- •Exclude patients whom in the Investigator's opinion, are hemodynamically unstable on the day of the procedure.
- •Untreatable allergy to contrast media
- •Patients who have undergone CT angiography within 48 hours of index PCI procedure
- •Patients with chronic total occlusions (CTOs) requiring intervention.
- •Patients requiring treatment for lesions other than the single bifurcated or single non-CTO complex lesion.
研究组 & 干预措施
Group A-CT Coregistration
5 subjects with CT co-registration in a magnetically navigated PCI (Group A)
干预措施: Percutaneous coronary intervention (Procedure)
Group B-Angiographic
5 subjects with angiographic co-registration in a magnetically navigated PCI (Group B)
干预措施: Percutaneous coronary intervention (Procedure)
Group C-Standard Angiography
5 subjects with standard angiography in a conventional PCI (Group C)
干预措施: Percutaneous coronary intervention (Procedure)
结局指标
主要结局
The primary endpoint is to compare and evaluate the total contrast use between Groups A, B and C .
时间窗: 6 months
次要结局
- The secondary endpoint is to compare and evaluate the following data points between Groups A, B and C: fluoroscopy time, procedure time, crossing time, procedural contrast use, adverse events (AEs): e.g. clinically significant perforations(6 months)